List of the Top 25 Quality Management Software for Microsoft 365 in 2026

HSI Donesafe's Quality Management Software prioritizes individuals in the quality assurance process. With immediate access to tools, you can tackle problems as they occur and work together effortlessly across different teams to promote ongoing enhancement. Streamline compliance and surpass expectations while fostering a culture of responsibility and creativity. Experience unparalleled configurability with our no-code platform. Adjust settings effortlessly whenever necessary using our user-friendly drag-and-drop feature. By enabling everyone, from frontline employees to management, this software cultivates a dedication to achieving outstanding results. Realize quality achievements that build confidence and guarantee sustainable success.

Qualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk. With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive. Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box. Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand. The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.

Propel's Quality Management solution empowers manufacturers to streamline, automate, and oversee their quality assurance processes. It integrates the management of nonconformances, CAPAs, deviations, complaints, and audits into a single, cohesive system that connects directly to product and change data. You can implement a comprehensive, cloud-based electronic Quality Management System (eQMS) within just 8 weeks, featuring all essential modules such as CAPA, Complaints, Non-Conformance Management Reports (NCMR), Audits, Deviations, Training, Equipment Calibration, and Supplier Quality. This setup does not require a Product Lifecycle Management (PLM) system. Designed specifically for industries under strict regulations, such as medical devices, this solution helps ensure compliance with FDA 21 CFR Part 820 & Part 11, ISO 13485:2016, EU MDR, and DHF/DMR through validated IQ/OQ/PQ documentation. With AI-driven features, the system creates training quizzes from quality data to bolster compliance efforts. Built-in workflows promote uniform processes while allowing for flexibility. Thanks to complete traceability, teams can achieve a 100% audit success rate and foster ongoing enhancements in product quality, all supported by robust enterprise-grade security measures.

The SBS QMS Suite is composed of five interrelated software modules designed to enhance Quality compliance efficiency. 1) The SBS Quality Database includes tools for managing CAPA and 8D corrective actions, overseeing nonconformance issues, conducting risk analyses such as FMEA and SWOT, handling various audit management needs, and ensuring Environmental Health and Safety (EHS/HSE) compliance. 2) SBS Ground Control focuses on managing employee training through a Learning Management System (LMS), offering self-paced training options, and providing document control features. 3) SBS Asset Tracking Database oversees calibrated equipment, preventive maintenance schedules, and comprehensive asset inventory management. 4) The SBS Inspection Database captures and records inspection data for incoming materials, in-process checks, and final product assessments, allowing for the generation of real-time SPC charts, development of inspection and control plans, and archiving data for future statistical evaluations. 5) The SBS Vendor Management maintains an approved vendor list (AVL), formulates vendor qualification plans, and tracks the qualification history of suppliers. Each of these modules may be purchased individually or in any combination to meet your needs. On-premise and cloud-based options are available. Free demos are available for download or contact us for a cloud-based demo.

Odoo is a highly customizable and open-source software solution that features a wide array of professionally crafted business applications. With its user-friendly database, Odoo addresses various business requirements, encompassing areas such as CRM, Sales, Projects, Manufacturing, Inventory, and Accounting. This versatile software is suitable for businesses of all sizes and budgets, making it an ideal choice for diverse company needs. The cohesive design of Odoo enhances operational efficiency and helps businesses save valuable time. Each module is designed to work harmoniously, providing a fluid experience as users navigate from one application to another. Automation capabilities allow users to streamline numerous tasks that would typically require manual entry across various systems. Odoo fosters collaboration among team members by consolidating all critical business functions onto a single platform, which ultimately enhances productivity and organization within the company. Furthermore, its adaptability ensures that businesses can continually evolve and tailor the system to their changing requirements.

QBench provides a comprehensive solution for monitoring all your samples and their positions within the workflow through a unified platform. By using QBench, you can forgo the traditional reliance on spreadsheets, shared network folders, and outdated paper tracking systems. The platform enables you to review numerous PDF reports and Certificates of Analysis (COAs) before finalizing or distributing them via email. You also have the option to create customizable barcodes and labels for your samples, ensuring compatibility with standard printers and scanners. Additionally, QBench features a billing module that streamlines the creation and dispatch of invoices directly from the system. Users can access data on counts and latencies for various data types within QBench, which encompasses metrics such as turnaround times, sample counts per test, delays, and more. This innovative tool simplifies the data collection process necessary for the assays conducted in your laboratory while enhancing overall efficiency. With QBench, managing your laboratory workflow has never been more straightforward and effective.

Artintech ERP is an all-inclusive enterprise resource planning system aimed at enhancing and simplifying business functions across multiple departments. Specifically designed for small to medium-sized enterprises (SMEs), it delivers powerful features within a user-friendly framework, enabling organizations to effectively oversee their resources, inventory, workforce, finances, and customer interactions through a single, cohesive platform. Why Opt for Artintech ERP? * Intuitive User Interface: Crafted for simplicity, Artintech ERP reduces the learning curve, facilitating a seamless transition and rapid acceptance throughout your organization. * Flexible Cloud Access: With our secure cloud-based solution, you can access your ERP system from anywhere at any time, providing the convenience to manage your business on the move. * Extensive Support Services: Our committed support team is here to guide you at every stage, from the initial setup through to continuous maintenance and upgrades, ensuring you get the most out of your ERP solution. This level of assistance allows you to focus more on growth and less on technical challenges.

The SBS Quality Database is an affordable and straightforward software solution that complies with ISO 9001 standards, enabling small enterprises to effectively oversee their Quality Management System (QMS). This tool facilitates the tracking of corrective and preventive actions (CAPA), internal audits, safety enhancements, supplier corrective actions, and ongoing improvement projects. Additionally, it allows for the compilation and analysis of customer survey feedback, as well as the identification and mitigation of risks through its risk management module, which includes FMEA and SWOT analysis. The program also permits documentation of QMS review meetings and their outcomes, along with the identification of interested parties as part of the organization's context. Users can utilize the dashboard for a snapshot of overall performance, with options available for both cloud-based and local installations. It is particularly suited for small businesses aiming for compliance with standards such as ISO 9001:2015, API Q1, AS9100, or TS16949. Prospective users can access free demo downloads from our website, allowing them to evaluate the software before making a purchase decision. Moreover, the system's intuitive design ensures that even those with minimal technical experience can navigate it efficiently.

The Adaptive Compliance Engine® (ACE®) is a versatile, workflow-driven eQMS/eDMS solution that can seamlessly adjust to various business processes, providing real-time oversight, management, and reporting for compliance, quality, and operational tasks. By utilizing ACE®, organizations can alleviate administrative burdens and enhance ROI through immediate productivity improvements, while maintaining adherence to 21 CFR Part 11 regulations. Our comprehensive software suite features: -Office 365 Integration -Inspection Management -Document Management -Risk Management -Product Lifecycle Management -Learning Management -Audit Management -Quality Events -Paperless Validation -Electronic Signatures (21 CFR Part 11 Compliant) -Endless Workflow Configurations -And numerous additional capabilities! Enable every tier of your organization with user-friendly interfaces, effortlessly locate all documents and records, and convert your data into insightful intelligence through advanced analytics, all within one unified platform. Every essential application is bundled together at a single price with ACE, eliminating the need for separate purchases. Enjoy the convenience of one software solution with countless functionalities, making it a truly invaluable asset for your business.

Qualcy Biomed's quality management system (QMS) software is tailored specifically for biomedical enterprises, such as those in biotechnology and pharmaceuticals, to effectively handle QMS documentation in line with FDA and ISO 13485 standards. It ensures adherence to 21 CFR Part 820 and incorporates essential features like electronic signatures, audit trails, and compliance with 21 CFR Part 11. Additionally, the software facilitates the management of document change control, complaint handling, audits, corrective and preventive actions (CAPA), non-conformance records, and training records, among other critical functions, ensuring a comprehensive solution for quality management. This robust platform ultimately supports organizations in maintaining high standards of compliance and operational efficiency in their quality processes.

With a platform that enables effortless operation, you can achieve outstanding quality and process efficiency. The E-Data Now® Audit & Quality Inspection Platform serves as a robust tool designed to enhance customer satisfaction, mitigate safety issues, and remove unnecessary processes. It encompasses all essential features to link team performance, streamline inspections, uncover the root causes of discrepancies, and refine procedures. This innovative platform, called E-Data Now!, is a cloud-based, no-code solution that delivers valuable insights into mobile data while automating various workflows. Eliminating excess paperwork can significantly declutter your audit process and help you pinpoint any redundancies in your audits. The straightforward answer lies in a platform that facilitates the creation of customized forms and mobile data collection, specifically tailored for tradespeople: empowering them to train, document, respond, adjust, ensure compliance, and establish improved processes for better overall efficiency. Additionally, this approach fosters a more organized work environment and promotes continuous improvement in operational standards.

The Intact Platform is a comprehensive Enterprise Resource Planning (ERP) solution available both in the cloud and on-premise, making it the ideal choice for audits, assessments, certifications, accreditations, and various standards. Unlike other audit collection tools, it provides an all-encompassing approach that facilitates the management of communications, business objectives, and personnel. With its unmatched capabilities, the Intact Platform features a fully integrated modular workflow that can be easily scaled to meet diverse needs. Users can expect an average efficiency increase of 34%, with potential gains exceeding 60%. Its exceptional modularity, flexibility, and scalability set it apart from competitors, while supporting all standards and audit services. Additionally, the platform operates through a digital workflow, eliminating the need for paper and enhancing both remote and on-site auditing experiences. It effectively manages non-conformities and corrective actions, while also enabling risk-based audit planning. Communication with clients is seamless, and the platform excels in reporting and business intelligence (BI). Centralized data management, including a comprehensive audit trail, ensures that all information is readily accessible, allowing for continuous innovation and improvement in auditing processes. As a result, the Intact Platform stands out as a vital tool for organizations striving for excellence in compliance and operational efficiency.

SimplerQMS provides a cloud-centric Quality Management Software tailored specifically for the Life Science sector. This innovative platform ensures adherence to an array of regulatory standards, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others, and is fully validated under GAMP5 guidelines. The software encompasses a comprehensive suite of Life Science QMS modules, including Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, and Quality KPIs, among additional functionalities. Moreover, SimplerQMS seamlessly integrates with Microsoft Office, enabling users to manage documents within familiar applications like Word, PowerPoint, and Excel. In summary, SimplerQMS not only streamlines operations through efficient, paperless workflows but also ensures that organizations can meet the stringent compliance mandates essential in the Life Science industry. Furthermore, its user-friendly interface and robust capabilities make it an indispensable tool for companies looking to enhance their quality management processes.

Cognidox serves as a comprehensive online document management system tailored for product development in the high-tech, life sciences, and medical device sectors. Available both in the cloud and as an on-premise solution, it fosters effective product lifecycle management and enhances knowledge sharing among developers, clients, partners, and customers alike. This platform is designed to be secure and dependable, offering plug-ins for a variety of programs, including Microsoft Office, and an API that facilitates the integration of numerous processes with Cognidox. At its core, Cognidox functions as a document management system, and it features an add-on that enables the licensing and distribution of documents to third parties through a fully sandboxed website, ensuring that specific documents can be published while maintaining the security of the main storage. Additionally, one of its notable add-ons is the gBMS, or Graphical Business Management System, which utilizes Visio to map out business processes effectively. A robust business management system not only enhances clarity across operations but also contributes to streamlined workflows and improved visibility throughout the organization.

Pro-Sapien is an EHS software solution integrated with Microsoft 365, specifically tailored for large enterprises with over 1,000 employees, facilitating easier EHS management throughout the organization. With its customizable modules for Incident Management, Audits, Inspections, Risk Assessment, and Permit to Work, Pro-Sapien serves as a comprehensive platform for EHS administration within Microsoft 365 environments. The mobile-responsive forms enable employees to maintain productivity while on the move, and the seamless integration with Teams ensures effortless accessibility. By digitizing EHS forms and automating workflows, organizations can gain valuable insights through Power BI to enhance their performance—all within a familiar platform. Discover how Pro-Sapien can benefit your organization by watching a brief demo video today, and explore the potential improvements it can bring to your EHS processes.

Harness the potential of effective quality management through TQA Cloud QMS Software, designed especially for small enterprises. Our platform is flawlessly integrated with the Microsoft 365 ecosystem, offering strong, dependable, and adaptable solutions tailored to meet your quality management requirements. Understanding that each business has its own distinct characteristics, we recommend selecting the provider that best fits your objectives to ensure an easy setup and installation experience. Immerse yourself in a realm of improved operational efficiency, optimized workflows, and reliable quality assurance with TQA Cloud QMS. Your success remains our utmost focus, so make the intelligent choice—choose TQA for your quality management needs and elevate your business to new heights.

BPAQuality365 is a quality management system (QMS) software that operates within the secure environment of Microsoft 365 cloud. It utilizes familiar tools that your team already engages with daily, eliminating the need for any alterations to user habits. This modern software is versatile, functioning seamlessly across all devices while being tailored to meet your specific requirements, and it harnesses the latest M365 technologies. The application boasts robust features for managing compliance documents, conducting audits, tracking non-conformances, implementing CAPA actions, and handling processes, process maps, incidents, changes, risks, FMEA, SWOT analyses, equipment, and health, safety, and environmental modules in adherence to ISO 9001, FDA Part 11, and medical regulations. Furthermore, the QMS application integrates smoothly with Teams, allowing users to inquire about the QMS during discussions and easily share QMS cards with colleagues. You can elevate your endeavors toward Quality 4.0 by leveraging advanced AI capabilities alongside superior workflow automation and insightful business intelligence. BPA's status as a Microsoft Preferred partner enables you to tailor your QMS according to your unique demands, collaborate effectively with power users, and deepen your understanding of M365 technologies, ultimately enhancing your organization's overall efficiency and compliance.

Are you a risk or quality manager looking for an effective solution to streamline your processes? With ISO2HANDLE, you gain enhanced control over your quality, safety, and human resources functions. This versatile software is applicable across various industries. Our platform offers a range of features, including risk and resource management, handling of complaints and tasks, risk assessments, registrations and notifications, document management (with audit capabilities), employee onboarding, performance evaluations, expense reporting, leave management, and environmental initiatives. Generating reports is effortless with just a single click, simplifying the audit process significantly. We take pride in assisting numerous companies globally, all while operating from our headquarters in the Netherlands, ensuring that our clients receive top-notch support and innovative solutions.

Elevate the standards of quality throughout your organization with a robust Electronic Quality Management System (EQMS) from Qualsys. This flexible and intuitive EQMS solution cultivates a more engaging and efficient work environment by providing a range of modules that enable each team member to assume responsibility for quality. Notable components include Document Manager, Training Manager, Risk Manager, Asset Manager, and Supplier Manager, among others, comprehensively covering all facets of quality management. By unifying these tools, organizations can enhance their operational workflows and strengthen compliance, which in turn fosters both employee satisfaction and customer loyalty. In doing so, they create a culture of continuous improvement that encourages innovation and accountability at all levels.

Orcanos is a unified eQMS and ALM platform designed specifically for medical device companies that need to manage regulated product development and quality operations together. The platform helps R&D, Quality, Regulatory, and Operations teams work from a single source of truth instead of relying on disconnected documents, spreadsheets, and siloed systems. Orcanos connects design control, quality management, document control, risk management, requirements, testing, validation, training, and audit evidence across the full medical device lifecycle. Its eQMS capabilities support quality processes such as document approvals, revision control, electronic signatures, training automation, CAPA, complaints, audits, nonconformances, and compliance records. Its ALM and design control tools help teams manage user needs, design inputs, risks, mitigations, verification, validation, DHF documentation, and automated impact analysis. Orcanos supports key medical device compliance needs, including ISO 13485, EU MDR, ISO 14971, FDA expectations, and 21 CFR Part 11 requirements. The platform is built for adaptive compliance, allowing teams to configure workflows, forms, fields, status flows, permission structures, and approval processes without heavy coding. Document control features help automate lifecycle routing, publishing, archiving, read-and-understand training tasks, and audit trails for every revision. Risk management becomes a live process by linking hazards, requirements, mitigations, design changes, and verification evidence in real time instead of maintaining static Excel files. Orcanos also includes Ask Paul, an AI-powered assistant designed to help users work more efficiently across regulated quality and development activities. With rapid implementation, traceability, configurable workflows, and centralized compliance data, Orcanos helps medical device teams reduce regulatory friction, stay audit-ready, and bring safer products to market faster.

Qualtrax is an advanced software solution designed for quality and compliance that facilitates the management and control of documentation, automates essential business processes, optimizes training management, oversees both internal and external audits, and guarantees adherence to vital industry regulations in real-time. This software proves to be an essential tool for organizations operating within tightly regulated sectors that must comply with standards like ISO 17025, 17020, 13485, 9001, TNI, GFSI, FDA, and FQS. By integrating these functionalities, Qualtrax not only enhances operational efficiency but also helps organizations mitigate risks associated with non-compliance.

Auditrunner offers a comprehensive solution for secure auditing, risk management, compliance, and quality assurance in software, available through both cloud and on-premise deployment options. With features like granular encryption and role-based access controls, all audit files and documents-at-rest are safeguarded effectively. The platform has successfully automated over 3000 business processes for organizations worldwide, showcasing just a fraction of its Governance, Risk, and Compliance (GRC) capabilities. Whether you choose cloud or on-premise, deployment is straightforward, allowing you to start reaping the benefits within weeks of initiation. Its seamless integration ensures minimal disruption as you transition to the platform. Additionally, the low-code architecture facilitates customization, enabling compliance with various standards and regulations. This allows businesses to thrive in a rapidly evolving regulatory landscape, adapting to numerous legislative requirements effortlessly. The unmatched ease of use positions Auditrunner as a leading choice for companies looking to enhance their compliance and audit processes efficiently.

Mindmaxx allows you to adeptly handle the vast assortment of your files, tasks, communications, reports, and schedules. This platform acts as an all-in-one library, communication center, and reminder system, integrating multiple functionalities into a single tool. A particularly noteworthy aspect of mindmaxx is its automatic update service, which ensures that any legal modifications are swiftly managed by the mindmaxx team, who will update and refresh the relevant documents. You will receive these updated documents directly and stay informed about changes, accompanied by practical advice on their application. Nevertheless, effective management transcends mere compliance with legal requirements; it also entails the identification and seizing of opportunities, establishing clear objectives, and taking proactive measures to achieve them, all of which are essential for thriving in today's competitive landscape. This proactive approach is increasingly critical in the modern workplace, and mindmaxx offers substantial support for you and your team as you navigate these challenges. Team members can easily access vital documents from a centralized hub, which significantly boosts collaboration and productivity. By cultivating such an organized atmosphere, mindmaxx not only streamlines operations but also empowers users to excel in their professional pursuits, ultimately contributing to overall success and growth.

CAQ.Net software solutions are utilized worldwide in scenarios where ensuring the quality, safety, and effectiveness of products and services is crucial. From strategic quality management to operational quality assurance, CAQ.Net enhances process management and encourages a company-wide commitment to quality through its advanced automation and consistent data framework, ultimately aiding in the proactive prevention of failures. This comprehensive approach not only streamlines operations but also fosters a culture of quality throughout the organization.

The AssurX platform serves as an advanced software solution for enterprise quality management (EQMS) and regulatory compliance, enabling effective communication and coordination of information, documentation, and activities. By utilizing AssurX, regulated organizations can swiftly pinpoint and manage quality concerns and risk factors, thereby preventing issues related to quality or compliance while also enhancing workflow efficiency. The QMS software from AssurX is specifically designed to be customizable, accommodating both stable and evolving business needs. It establishes a digital workflow encompassing tasks, alerts, escalations, and approvals, which can be automated according to specific requirements, accurately reflecting real-world processes. There is no other system that matches its ease of deployment, configuration, and adaptability, making it a standout choice for businesses. In addition, AssurX solutions work together seamlessly to form an interconnected quality management system. These offerings include features such as audit management, corrective actions, training management, complaint management, document management, change control, risk management, and EHS incident management, among others, ensuring comprehensive coverage of quality management needs. Ultimately, the integration of these solutions supports organizations in achieving higher standards of quality and compliance across their operations.